FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Centessa Promising Data for Sleep Disorder Drug

[ Price : $8.95]

Centessa Pharmaceuticals reports encouraging clinical data for its oral OX2R agonist ORX750 in patients with narcolepsy Types 1 an...

Liebel-Flarsheim CGMP Violations Cited

[ Price : $8.95]

FDA warns Liebel-Flarsheim in Raleigh, NC, about CGMP violations in its production of finished drugs.

Alembic Pharmaceuticals FDA-483 Out

[ Price : $8.95]

FDA releases the form FDA-483 with four observations from an inspection at the Alembic Pharmaceuticals active pharmaceutical ingre...

HR Complaints Filed Against Prasad: Report

[ Price : $8.95]

A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vi...

FDA Rejects Biohavens Troriluzole Application

[ Price : $8.95]

FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocereb...

FDA Warns Apotex Canadian Manufacturing Site

[ Price : $8.95]

FDA issues a Warning Letter to Apotex, citing significant GMP violations at the companys Richmond Hill, Ontario, facility, includi...

White House Supporting Makary in Turmoil: Report

[ Price : $8.95]

Politico reports that President Trump and HHS are standing by FDA commissioner Marty Makary as the agency weathers the sudden depa...

Sydnexis Pediatric Myopia Drug Meets Endpoints

[ Price : $8.95]

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase...

Can Industry Accept a Dysfunctional FDA?: Axios

[ Price : $8.95]

An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can...

Sarepta Completes Confirmatory Duchenne Trial

[ Price : $8.95]

Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy dru...